Director, Small Molecule Process Development
Location: Thousand Oaks
Posted on: June 23, 2025
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Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds toughest diseases. With our
focus on four therapeutic areas Oncology, Inflammation, General
Medicine, and Rare Disease we reach millions of patients each year.
As a member of the Amgen team, youll help make a lasting impact on
the lives of patients as we research, manufacture, and deliver
innovative medicines to help people live longer, fuller happier
lives. Our award-winning culture is collaborative, innovative, and
science based. If you have a passion for challenges and the
opportunities that lay within them, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. Director, Small Molecule Process
Development What you will do Lets do this. Lets change the world.
In this vital role you will be part of Amgens Process Development
organization, Drug Substance Technologies Synthetics (DSTS) plays a
vital role in developing robust drug substance manufacturing
processes to serve patients. Specifically, DSTS is an integrated
organization of small molecule process chemists and engineers that
is accountable to invent, develop, and deploy drug substance
manufacturing processes and technologies to advance Amgens
synthetic and hybrid portfolio. In this role, the Director is
responsible for leading a team of process chemists that drive all
aspects of commercial process development, process design, process
characterization, site selection for commercial manufacturing, and
technology transfer for our synthetic portfolio, inclusive of
hybrid modalities (e.g., peptides, oligonucleotides and
bioconjugates). This is an on-site role based out of our Amgen
Thousand Oaks, CA headquarters and reports to the Senior Director
of Process Development. Accountable for leading a team of process
chemists, ensuring that the DSTS mission and vision are implemented
and upheld Accountable to advance a complex and diverse synthetics
portfolio of molecules including small molecules, bioconjugates,
ADCs, peptides, and oligonucleotides from research through to
commercialization working with our partners across Operations and
our internal and external manufacturing network Effectively manage
performance and career development for staff and develop the next
generation of leaders from within the department Directly
responsible for department-wide activities (e.g., budgeting,
capital allocation, project assignment, alignment initiatives,
setting vision/direction/strategy and technology development)
Ensures that industry standards and best practices that fit Amgens
business needs are effectively applied Represents Drug Substance
Technologies as a scientific, regulatory and technical expert both
internally and externally Evaluates, resolves and/or escalates
issues in a timely manner Serves as a technical expert in small
molecule and hybrid modalities and keeps current in drug substance
development, including literature and technology development for
cutting edge and regulatory driven activities Understands the
technical and/or scientific capabilities of the department and
provides guidance to all junior and senior staff members to resolve
scientific/technical issues Conveys a broader level of
understanding in pharmaceutical R&D and commercialization to
the department Extensive knowledge of GLP and GMP activities
Clearly understands and applies knowledge of regulatory
requirements (FDA, ICH, USP, etc.) to completion of projects Leads
and/or participates in technical forums for sharing of best
practices and application of scientific expertise Oversees and
upholds proper safety practices Provides oversight for pipeline
projects through their experience and leadership in scientific,
technical and regulatory issues Leads by example: Creative,
hard-working, responsive, flexible, and with a demonstrated
willingness to adjust in a landscape of constantly changing program
outcomes and priorities Aligns project resources with program
status, projected activities, and organizational prioritization.
Ensures that effective teams are built and sustained within the
department Facilitates cohesiveness, fosters engagement, and builds
team spirit Provides feedback through coaching and effective
performance appraisal and development planning Initiates and
encourages scientific discourse and effective collaboration with
groups outside the department Anticipates, proactively detects, and
addresses problems related to departmental and inter departmental
activities Communicates effectively with others, using appropriate
diplomacy, sensitivity, and confidentiality where required
Establishes and maintains effective communication mechanisms to
keep staff appropriately informed Bridges communication between
individuals, units and other organizations as necessary Informs and
consults management and senior leaders appropriately What we expect
of you We are all different, yet we all use our unique
contributions to serve patients. The professional we seek is a
leader with these qualifications. Basic Qualifications: Doctorate
degree and 4 years of Scientific, Process Development and/or
Technical Service experience Or Masters degree and 8 years of
Scientific, Process Development and/or Technical Service experience
Or Bachelor's degree and 10 years of Scientific, Process
Development and/or Technical Service experience and In addition to
meeting at least one of the above requirements, you must have at
least 4 years experience directly managing people and/or leadership
experience leading teams, projects, programs, or directing the
allocation or resources. Your managerial experience may run
concurrently with the required technical experience referenced
above Preferred Qualifications: PhD with 10 years of relevant
experience in the pharmaceutical or related industry which includes
leadership of scientific project teams, and successful leadership
of drug substance project groups Excellent knowledge of synthetic
organic chemistry, chemical process development, process
characterization and validation, and technology transfer Excellent
technical communication skills, both written and verbal, to
interact effectively with all stakeholders Strong problem-solving
skills, including application of scientific theory Strong
experience with regulatory requirements for API/Product (CMC for
IND/NDA, GLP/GMP, ICH) Experience in authoring briefing books,
investigational new drug applications, marketing authorization
applications, and responses to regulatory questions Well-recognized
and established in the scientific community through a record of
peer-reviewed publications and/or patents Demonstrated success
developing staff, including effective feedback and coaching What
you can expect of us As we work to develop treatments that take
care of others, we also work to care for your professional and
personal growth and well-being. From our competitive benefits to
our collaborative culture, well support your journey every step of
the way. The expected annual salary range for this role in the U.S.
(excluding Puerto Rico) is posted. Actual salary will vary based on
several factors including but not limited to, relevant skills,
experience, and qualifications. In addition to the base salary,
Amgen offers a Total Rewards Plan, based on eligibility, comprising
of health and welfare plans for staff and eligible dependents,
financial plans with opportunities to save towards retirement or
other goals, work/life balance, and career development
opportunities that may include: A comprehensive employee benefits
package, including a Retirement and Savings Plan with generous
company contributions, group medical, dental and vision coverage,
life and disability insurance, and flexible spending accounts A
discretionary annual bonus program, or for field sales
representatives, a sales-based incentive plan Stock-based long-term
incentives Award-winning time-off plans Flexible work models,
including remote and hybrid work arrangements, where possible Apply
now and make a lasting impact with the Amgen team.
careers.amgen.com In any materials you submit, you may redact or
remove age-identifying information such as age, date of birth, or
dates of school attendance or graduation. You will not be penalized
for redacting or removing this information. Amgen does not have an
application deadline for this position; we will continue accepting
applications until we receive a sufficient number or select a
candidate for the position. As an organization dedicated to
improving the quality of life for people around the world, Amgen
fosters an inclusive environment of diverse, ethical, committed and
highly accomplished people who respect each other and live the
Amgen values to continue advancing science to serve patients.
Together, we compete in the fight against serious disease. Amgen is
an Equal Opportunity employer and will consider all qualified
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, national origin,
protected veteran status, disability status, or any other basis
protected by applicable law. We will ensure that individuals with
disabilities are provided reasonable accommodation to participate
in the job application or interview process, to perform essential
job functions, and to receive other benefits and privileges of
employment. Please contact us to request accommodation.
Keywords: , Arcadia , Director, Small Molecule Process Development, Science, Research & Development , Thousand Oaks, California
